The application covers patients whose disease has progressed despite treatment with at least two therapies, including Revlimid (lenalidomide) and a proteasome inhibitor — such as Velcade (bortezomib), Kyprolis (carfilzomib), or Ninlaro (ixazomib).

In the study, researchers assessed if Empliciti combined with Pomalyst and low-dose dexamethasone was more efficient at delaying disease progression or death in relapsed/refractory multiple myeloma patients than Pomalyst and dexamethasone alone.

Empliciti is an antibody that specifically targets and binds to a molecule called signaling lymphocyte activation molecule family member 7 (SLAMF7). This molecule is present on both the surface of myeloma cells and natural killer cells (NK), a type of immune cell that helps the body destroy tumors.

This investigational compound works in two complementary ways: By binding to NK cells, Empliciti activates a patient’s immune system, and by binding to myeloma cells, it tags them for NK cell-mediated destruction.

Trial participants included 117 patients who had failed at least two prior lines of therapy, including Revlimid and a proteasome inhibitor.

Results showed that patients treated with the triple combination lived longer without disease progression (10.3 months versus 4.7 months in the control group), and the treatment had an acceptable safety profile. The overall response rate was also better in the triple combination — 53% versus 26%.

Overall, the trial’s results support the addition of Empliciti to Pomalyst and dexamethasone for advanced myeloma patients who failed to respond to prior treatment with Revlimid and a proteasome inhibitor.

“This file acceptance is an important step in BMS’s ongoing efforts to advance treatment options for patients with relapsed/refractory multiple myeloma,” Jeffrey Jackson, PhD, hematology development lead at Bristol-Myers Squibb, said in a press release.

“Given the need for new, effective treatment options in this patient population, we look forward to working with the FDA with the hope of bringing this combination to patients with RRMM whose disease progressed on previous therapies as quickly as possible,” he said.

Patricia holds her Ph.D. in Cell Biology from University Nova de Lisboa, and has served as an author on several research projects and fellowships, as well as major grant applications for European Agencies. She also served as a PhD student research assistant in the Laboratory of Doctor David A. Fidock, Department of Microbiology & Immunology, Columbia University, New York.

Disclaimer:

Myeloma Research News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

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